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Viaskin Milk · 1 trial · 1 indication
A treatment responder is defined as a subject who meets at least one of the following criteria: * A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins; * A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.
| Arm | Type | Description |
|---|---|---|
| Viaskin Milk 150 mcg | EXPERIMENTAL | One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months. |
| Viaskin Milk 300 mcg | EXPERIMENTAL | One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months. |
| Viaskin Milk 500 mcg | EXPERIMENTAL | One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months. |
| Viaskin Placebo | PLACEBO_COMPARATOR | One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months. |
| Name | Type | Description |
|---|---|---|
| Viaskin Milk 150 mcg | BIOLOGICAL | Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins. |
| Viaskin Milk 300 mcg | BIOLOGICAL | Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins. |
| Viaskin Milk 500 mcg | BIOLOGICAL | Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins. |
| Viaskin Placebo | BIOLOGICAL | Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation. |
Eligibility criteria for study enrollment: Inclusion Criteria: * Signed Informed Consent Form (ICF) by parent(s)/guardian(s) of subjects and informed assent form (IAF) for subjects ≥7 years, or as per local or country specific guidelines or regulations. * Male or female subjects 2 to 17 years old ...
Viaskin Milk is an investigational treatment for IgE-mediated cow's milk allergy in children. It is being developed as a potential therapy for food allergy, specifically targeting allergic reactions to cow's milk protein. The product is currently in clinical development and has not been approved by regulatory authorities.
Viaskin Milk is being developed by DBV Technologies S.A., a biopharmaceutical company listed on the stock exchange under the ticker symbol DBVT. The company is conducting clinical research to evaluate the safety and efficacy of this investigational product for the treatment of cow's milk allergy.
Viaskin Milk is in Phase 1 clinical development. It is an investigational product, meaning it has not yet been approved for commercial use. The Phase 1 trial has been completed, and the product remains under evaluation for its potential role in treating IgE-mediated cow's milk allergy in children.
Viaskin Milk has been studied in a completed Phase 1 clinical trial registered as NCT02223182. This trial, titled 'Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy,' enrolled 198 participants aged 2 years and older in the United States and Canada. The study was randomized, double-blind, and placebo-controlled.
Viaskin Milk is not FDA approved. It is an investigational product currently in Phase 1 clinical development. The completed clinical trial, NCT02223182, evaluated its safety and efficacy in children with IgE-mediated cow's milk allergy, but regulatory approval has not been granted.